BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE1 PUMP UNREFURB

    MDR report key: 1993540 · Received February 16, 2011

    Report

    Report Number
    6000001-2011-01054
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 29, 2011
    Report Date
    January 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF FAILURE TO AUDIBLY ALARM WITH A CONSTANT 550:320:654:0000 FAILURE CODE WAS CONFIRMED THROUGH EVALUATION. THE CONDITION IS DUE TO A FAULTY MAIN SPEAKER. THE MAIN SPEAKER WAS REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Additional Manufacturer Narrative · 1

    BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). THE DEVICE HAS NOT BEEN SERVICED BY BAXTER PRIOR TO THIS EVENT. NO EXCEPTIONS OCCURRED DURING THE MANUFACTURING OF THIS DEVICE. (B)(4).

    Description of Event or Problem · 1

    DURING SERVICE EVALUATION OF A COLLEAGUE INFUSION PUMP, A FAILURE TO AUDIBLY ALARM OCCURRED WITH A CONSTANT 550:320:654:0000 FAILURE CODE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION NECESSARY. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90 CATEGORIZED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE1 PUMP UNREFURB PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1